Assessing young adults' menopause knowledge to increase understanding of symptoms and help improve quality of life for women going through menopause; a student survey.

BACKGROUND: Due to menopause being a largely invisible and under-discussed topic in wider society, women often deal with menopause-related complications on their own. Social support and awareness have been shown to reduce negative menopausal experiences; however, lack of menopause knowledge, particularly among younger people, may deter support for women suffering from menopause symptoms. This study aims to assess the level of knowledge young adults have on menopause to be able to create interventions that target knowledge gaps and increase understanding of women's experiences and difficulties during their menopause transition. METHODS: We created an electronic questionnaire based on menopause literature and guidelines from Menopause Societies. It was pilot-tested on young people in the target group age (n = 14; 7 male and 7 female), menopause clinicians (n = 5), and women experiencing menopause (n = 4). The final survey included questions on participant demographics, general menopause knowledge, and options to support menopause management and was distributed through university student newsletters. Responses over a two week period were collected anonymously. Descriptive statistics were applied to characterize participants, define menopause knowledge, and identify gaps. Chi-squared statistics was used for group comparison, and open questions were analyzed using qualitative content analysis. RESULTS: Survey responses were collected from 828 students; the average age was 22.1 ± 5.1 and 83.6% were female. Participants belonged to all faculties and included students from a variety of family settings and living conditions. Knowledge questions revealed a good understanding of the basic menopause physiology for most respondents, but there were gaps in understanding of symptoms and symptom management. Female sex and personal connection to menopausal women had a positive effect on the degree of menopause knowledge. Both males and females reported increased knowledge confidence at the end of the survey. CONCLUSION: Our survey provides evidence that young adults of both sexes have a general baseline knowledge of menopause and its symptoms and are open to learning strategies to help support menopausal women. Our findings will assist in developing targeted educational resources to increase social support and awareness, reduce stigma and improve the quality of life for menopausal women, and help prepare younger women for their future menopause journey.

Nehiyawak (Cree) women's strategies for aging well: community-based participatory research in Maskwacîs, Alberta, Canada, by the Sohkitehew (Strong Heart) group.

BACKGROUND: The Sohkitehew (Strong Heart) Research Group, which included an Elders Advisory Committee of seven Nehiyawak (Cree) women, set out to bring Maskwacîs community members together to understand Nehiyawak women's experiences of "aging well". The goals of this research were to generate information honouring Indigenous ways of knowing, and gather strengths-based knowledge about aging well, to help Maskwacîs, women maintain wellness as they age. METHODS: We facilitated qualitative Sharing Circles in three different settings in Maskwacîs. Discussions were prompted using the four aspects of the self, guided by Medicine Wheel teachings: Physical, Mental, Emotional, Spiritual. Detailed notes were recorded on flip charts during the discussions of each Sharing Circle. Data were analysed using descriptive content analysis to identify practical strategies for aging well. RESULTS: Thirty-six community members attended one or more Sharing Circle. Strategies included: Physical-keeping active to remain well; Mental-learning new skills to nourish your mind; Emotional-laughing, crying, and being happy; Spiritual-practicing Nehiyawak traditional ways. Participants commented that balancing these four aspects of the self is necessary to achieve wellness. Following the analysis of the Sharing Circle comments, three community feedback sessions were held to discuss the results in the wider community. These strategies were formatted into a draft booklet which incorporated Cree language, and archive photographs of Maskwacîs women and families. CONCLUSIONS: The Nehiyawak Sharing Circles identified practical strategies that help women to remain well as they age. This positive approach to aging could be adopted in other Indigenous and non-Indigenous communities.

The (commercialised) experience of operating: Embodied preferences, ambiguous variations and explaining widespread patient harm.

This article provides a detailed account of how surgeons perceived and used a device-procedure that caused widespread patient harm: transvaginal mesh for the treatment of pelvic floor disorders in women. Drawing from interviews with 27 surgeons in Canada, the UK, the United States and France and observations of major international medical conferences in North America and Europe between 2015 and 2018, we describe the commercially driven array of operative variations in the use of transvaginal mesh and show that surgeons' understanding of their hands-on, sensory experience with these variations is central to explaining patient harm. Surgeons often developed preferences for how to manage actual and anticipated dangers of transvaginal mesh procedures through embodied operative adjustments, but collectively the meaning of these preferences was fragmented, contested and deferred. We critically reflect on surgeons' understandings of their operative experience, including the view that such experience is not evidence. The harm in this case poses a challenge to some ways of thinking about uncertainty and errors in medical sociology, and calls for attention to a specific feature of surgical work: the extent and persistence of operative practices that elude classification as right or wrong but are still most certainly better and worse.

Development and validation of a case definition for problematic menopause in primary care electronic medical records.

BACKGROUND: Menopause is a normal transition in a woman's life. For some women, it is a stage without significant difficulties; for others, menopause symptoms can severely affect their quality of life. This study developed and validated a case definition for problematic menopause using Canadian primary care electronic medical records, which is an essential step in examining the condition and improving quality of care. METHODS: We used data from the Canadian Primary Care Sentinel Surveillance Network including billing and diagnostic codes, diagnostic free-text, problem list entries, medications, and referrals. These data formed the basis of an expert-reviewed reference standard data set and contained the features that were used to train a machine learning model based on classification and regression trees. An ad hoc feature importance measure coupled with recursive feature elimination and clustering were applied to reduce our initial 86,000 element feature set to a few tens of the most relevant features in the data, while class balancing was accomplished with random under- and over-sampling. The final case definition was generated from the tree-based machine learning model output combined with a feature importance algorithm. Two independent samples were used: one for training / testing the machine learning algorithm and the other for case definition validation. RESULTS: We randomly selected 2,776 women aged 45-60 for this analysis and created a case definition, consisting of two occurrences within 24 months of International Classification of Diseases, Ninth Revision, Clinical Modification code 627 (or any sub-codes) OR one occurrence of Anatomical Therapeutic Chemical classification code G03CA (or any sub-codes) within the patient chart, that was highly effective at detecting problematic menopause cases. This definition produced a sensitivity of 81.5% (95% CI: 76.3-85.9%), specificity of 93.5% (91.9-94.8%), positive predictive value of 73.8% (68.3-78.6%), and negative predictive value of 95.7% (94.4-96.8%). CONCLUSION: Our case definition for problematic menopause demonstrated high validity metrics and so is expected to be useful for epidemiological study and surveillance. This case definition will enable future studies exploring the management of menopause in primary care settings.

Menopause experience in First Nations women and initiatives for menopause symptom awareness; a community-based participatory research approach.

BACKGROUND: Little research has been conducted about menopause in First Nations women. In response to the wishes of Cree women living in Maskwacis, Alberta, to start a dialogue on menopause, we undertook community-based participatory research (CBPR) to explore menopause experience and raise awareness of menopause symptoms in the community. METHODS: The research adhered to the principles of Ownership, Control, Access and Possession (OCAP™) and was guided by the interest of the participating women. Local women (target age 40-65 years) were invited to participate in workshops using word-of-mouth and community posters in health centers. Five research workshops were held in community settings, attended by experienced women's health researchers and consenting women. The participants guided the informal discussions. They also completed questionnaires which included menopause-related quality of life. The researchers used extensive hand-written field notes to record data; qualitative content analysis was applied to identify themes. Simple descriptive analysis was used for the questionnaire results. The findings were discussed at a community feedback session and laid the basis for further knowledge translation initiatives. RESULTS: The five workshops included a total of 37, mostly post-menopausal women with 6-11 women/workshop. The main discussion themes were: "experiences of menopause symptoms" including their impact on quality of life; "menopause knowledge prior to their own experience" with most women feeling that they had insufficient information before menopause; "menopause symptom management" which mainly included practical strategies; "impact of menopause on family members" which was of prime concern with uncontrollable mood changes affecting the whole family and sometimes causing matrimonial disharmony. Questionnaire responses corroborated the workshop discussions. Knowledge translation of the research findings produced two information pamphlets specifically for the Maskwacis community: one for husband/partner, the other for women and family members. These pamphlets have been distributed in all areas of the community. CONCLUSION: This CBPR project addressed a topic identified by the community as being important. Community members developed informative pamphlets in response to the women's concern of lack of understanding for menopause symptoms among families. This simple solution has been widely accepted by community members, opening the possibility of wider discussion about menopause.

Contraception Use and Attitudes Among Women Seeking Pregnancy Termination: Descriptive Cross-Sectional Survey.

OBJECTIVE: Unintended pregnancy has been linked to poor health and social outcomes for both mother and child. Efforts to reduce unintended pregnancies have been challenged by many financial, social, religious, and cultural factors. This study aimed to investigate how contraception use and misuse in a cohort of females seeking termination of pregnancy contribute to unintended pregnancies. METHODS: We conducted a cross-sectional study with women presenting to a women's health clinic for pregnancy termination from April to December 2017. Consenting participants completed a self-administered, confidential questionnaire that included questions on demographic, ethnic, and social characteristics, as well as behaviours and attitudes related to contraception. Data analysis used descriptive statistics. RESULTS: Data were collected from 334 women; about half (45%) had used contraception at the time of conception, representing a variety of different methods. Contraceptive use was associated with higher education, stable relationship status, and ethnic majority status but not with previous pregnancies or immigration status. Among contraceptive users, imperfect and inconsistent use of contraception (50% and 31%, respectively), and method failure (48%), including condom breakage, were cited as reasons for the current pregnancy. Non-users reported perceived low risk of pregnancy (55%), concerns about contraception (47%), and problems accessing contraception (27%). While the majority of participants were aware of emergency contraception, only 52% reported ever using it. Most participants (89%) planned to use contraception in the future. CONCLUSION: Our study highlights contraceptive behaviours and patterns of individuals seeking abortion. Patient-centered contraceptive counselling in order to facilitate contraceptive choice and access can include information about the most effective contraceptives and the need for back-up contraception methods.

Walking together: women with the severe symptoms of menopause propose a platform for a walking program; outcome from focus groups.

BACKGROUND: Menopause and midlife are stages in a woman's life that can be marked by debilitating symptoms and increasing risks for cancer, cardiovascular, metabolic, and bone health issues. Walking represents a simple, low cost, and widely accessible activity with proven health benefits, though its therapeutic effect on alleviating menopause symptoms is not well characterized. Women are generally not opposed to exercise programs; however, increasing or maintaining exercise levels remains a challenge. We undertook a qualitative descriptive study to explore features of a walking program that would be conductive to menopausal women's participation, as well as to inform the development of such a program. METHODS: We conducted focus groups with women recruited from two menopause clinics and who suffered from moderate to severe menopause symptoms. The focus groups were audio recorded and transcribed. Women were prompted to talk about their menopause experience and exercise practice and how they would envision a walking exercise program that would keep them engaged. Qualitative content analysis was used to analyze the data and to identify characteristics of a walking exercise program. RESULTS: Twenty women participated in 5 focus groups. Women were very interested in trying walking as a means of staying healthy and possibly reducing menopause symptoms. Four major characteristics emerged as important for a walking program: (a) sensitivity to health realities of menopausal women, (b) inclusivity of various needs/levels of physical ability, (c) attentiveness to the need for mutual social support, (d) flexibility in planning of locations and scheduling. A restricted social network platform with features catering to women in menopause was suggested as suitable to initiate and sustain an adequate walking program. CONCLUSIONS: The findings of this study will be essential in designing a program that would be attractive for women to start and maintain a walking habit. The program would assist in elucidating whether walking is a useful and valuable alternative therapy for menopausal symptoms and, ultimately, might help women staying fit in midlife and postmenopausal.

Taking the Leap Toward Cost-Conscious Education in Obstetrics and Gynaecology: A Preliminary Randomized Controlled Trial.

OBJECTIVE: Residents have a professional obligation with respect to the stewardship of health care resources, yet there is a paucity of research on how to improve residents' cost-awareness. Rising health care expenditures highlight a critical need to improve education related to this competency. This study aimed to test if an educational module can teach residents to make cost-conscious decisions and reduce health care spending. METHODS: All Canadian obstetrics and gynaecology residents in 2017 were eligible to participate in this randomized controlled trial. The study was administered online via REDCap. Interested residents were enrolled, stratified by level of training, and block randomized. Residents completed a survey to determine their management of 4 obstetrical scenarios. The intervention group reviewed an educational module on cost-effective ordering prior to completing the survey; the control group was given the option to review the module afterward. The primary outcome was mean total expenditures, compared between the 2 groups using the t test. RESULTS: Eighty-five residents were enrolled between August and November 2017, and 63 residents from 13 Canadian residency programs completed the study requirements (33 control and 30 intervention). Mean total expenditure was CAD$291.03 (95% CI 259.38-322.68) versus CAD$192.98 (95% CI 170.67-215.29) for the control and intervention groups, respectively. These figures corresponded to a 33.69% or CAD$98.05 reduction in total expenditures (P = 0.0001). CONCLUSION: This educational module decreased expenditures by Canadian obstetrics and gynaecology residents managing hypothetical obstetrical cases. This introduces a potential curriculum innovation to improve resident education in judicious use of health care resources.

Does Cost Influence the Choice of Disposable Versus Reusable Instruments? Mailed Survey of Obstetrician/Gynaecologists.

OBJECTIVE: A "cost-awareness" campaign was undertaken at a tertiary hospital from 2015 to 2016 to raise awareness about costs of disposable versus reusable instruments in laparoscopic procedures. We undertook a before and after survey of obstetrician/gynecologists (Ob/Gyns) to find out if the campaign had affected their attitudes about choosing disposable versus less expensive reusable instruments. METHODS: In 2015 (before the cost-awareness campaign) and 2017 (after the cost-awareness campaign), all full-time university-associated Ob/Gyns were mailed a cover letter, questionnaire, and coffee card ($5) with a postage-paid return envelope. Responses (with unique identification) from Ob/Gyns who perform laparoscopic procedures were entered into a password-protected REDCap database on a secure server. All statistical analyses were performed using SAS software version 9.4 (SAS Institute Inc, Cary, NC) (Canadian Task Force Classification II-3). RESULTS: A total of 35 of 42 eligible Ob/Gyns (85%) with a median 10 years in practice completed questionnaires before and after the intervention. The majority had undertaken minimally invasive surgery training, mainly during residency (80%) and conferences (71%). Before the intervention, the three most important qualities influencing their decision to use a particular instrument were safety (66%), effectiveness (57%), and personal experience (49%). After the intervention, the three most important qualities were effectiveness (57%), safety (57%), and ease of use (46%). Device cost was ranked sixth (26%) before and seventh (17%) after the intervention. The majority (57%) of participants did not change their choice of disposable or reusable instruments, or they would make the choice according to the specific procedure. CONCLUSION: Given the current economy, operative costs are constantly under review. Knowledge about Ob/Gyns' attitudes provides information to design more effective awareness campaigns to encourage use of less costly instruments. To change practice, a campaign increasing Ob/Gyns' exposure to less expensive but safe and effective instruments may help to increase uptake and potentially lead to cost reduction. Cost awareness alone is unlikely to change practice.

No. 186-Conservative Management of Urinary Incontinence.

OBJECTIVE: To outline the evidence for conservative management options for treating urinary incontinence. OPTIONS: Conservative management options for treating urinary incontinence include behavioural changes, lifestyle modification, pelvic floor retraining, and use of mechanical devices. OUTCOMES: To provide understanding of current available evidence concerning efficacy of conservative alternatives for managing urinary incontinence; to empower women to choose continence therapies that have benefit and that have minimal or no harm. EVIDENCE: The Cochrane Library and Medline (1966 to 2005) were searched to find articles related to conservative management of incontinence. Review articles were appraised. VALUES: The quality of evidence is rated, and recommendations are made using the criteria described by the Canadian Task Force on Preventive Health Care. BENEFITS, HARMS, COSTS: Evidence for the efficacy of conservative management options for urinary incontinence is strong. These options can be advocated as primary interventions with minimal or no harm to women.

Do Patients Understand the Role of Resident Physicians in the Operating Room? A Survey of Gynaecology Patients.

OBJECTIVE: Studies from disciplines outside gynaecology have found that most patients do not understand the clinical responsibilities allocated to physicians-in-training. No research on this topic has been published in gynaecology, despite litigation against gynaecological surgeons regarding the role of residents in surgery. The goal of this research was to explore what gynaecological surgery patients understand about the role of resident doctors. METHODS: A questionnaire was distributed to female patients in gynaecological surgery pre-admission clinics in Edmonton, Alberta. Surveys included knowledge and opinion statements about residents' duties. Anonymous responses were entered into a secure database. Descriptive statistics were used to characterize the results. RESULTS: Of 108 participants, 83% understood that residents had a higher level of training than medical students, yet 40% were unsure whether residents were doctors. Almost one half (43%) of participants were uncertain whether residents required supervision, including while operating (20%). Most (92%) believed it was important to know their physician's level of training, yet only 63% reported knowing this information. Only 50% of participants would be comfortable with residents operating on them under supervision. A considerable number (56%) wanted to learn more about residents' roles. CONCLUSION: Patients do not fully understand the role of residents, and many are uncomfortable with trainees operating on them under supervision. Considering the significant role of residents in patient care, educating patients is essential to improve their comfort and the overall consent process.

Ondansetron in Pregnancy and the Risk of Congenital Malformations: A Systematic Review.

OBJECTIVE: Ondansetron, not approved for use in pregnancy, is increasingly being prescribed for nausea and vomiting in pregnancy and hyperemesis gravidarum. A number of recent lawsuits have highlighted the possibility that ondansetron may cause congenital malformations. The aim of this study was to systematically review epidemiological evidence on the potential association of prenatal exposure to ondansetron and congenital malformations. METHODS: Systematic searches in Medline and Embase were performed in June 2017 using controlled vocabulary and key words, and references of search results were reviewed. Full papers (RCTs, cohort, and case-control studies) were eligible for inclusion if they reported fetal outcomes of prenatal ondansetron exposure in humans. Excluded were: case reports, studies involving pre-medication with ondansetron prior to CS, animal studies, and foreign languages studies. RESULTS: Ten epidemiologic studies were included: five large retrospective cohort studies, two prospective observational studies, two population-based case-controls. and a retrospective case series. Sample sizes ranged from 17 to 1 501 434 infants exposed to ondansetron. A case-control study identified an association between prenatal exposure to ondansetron and cleft palate, and one cohort study found an increased risk of cardiovascular defects. These findings were not reproduced in the other studies. CONCLUSION: While further investigation of the literature is needed, our results highlight the paucity of evidence linking prenatal exposure to ondansetron to an increased risk of congenital malformations. There is a need for additional epidemiologic studies to confirm whether ondansetron represents a safe and effective alternative treatment for nausea and vomiting in pregnancy and hyperemesis gravidarum.

Five years after midurethral sling surgery for stress incontinence: obesity continues to have an impact on outcomes.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the impact of preoperative body mass index ≥30 on objective and subjective cure rates 5 years after midurethral sling surgery. METHODS: Secondary analysis of the 5-year results of a randomized clinical trial evaluating tension-free vaginal tape vs transobturator tape surgery. Women (n = 176) were classified as obese or non-obese based on preoperative height and weight. Women self-reported symptoms and quality of life, and underwent standardized physical examinations and pad-testing. Categorical data were analyzed using Chi-squared or Fisher's exact tests, continuous data by Mann-Whitney U test. Primary outcome was objective cure defined as <1 g urine lost on pad-test at 5 years post-surgery. Secondary outcomes were subjective cure of incontinence, urinary urge incontinence symptoms, and quality of life scores. RESULTS: Non-obese women had a higher rate of objective cure, 87.4 % (n = 83 out of 95) compared with 65.9 % (n = 29 out of 44) in the obese group (P = 0.003, risk difference [RD] 21.5 %, 95 % CI 5.9-37.0 %). Subjectively, non-obese women also reported higher rates of cure, 76.7 % (n = 89 out of 116) compared with 53.6 % (n = 30 out of 56) of obese women (P = 0.002, RD 23.2 %, 95 % CI 8.0-38.3 %). Overall rates of urge incontinence symptoms were similar in the two groups, but rates of bothersome symptoms were higher for obese women (58.9 % vs 42.1 %, P = 0.039, RD 16.8 % 95 % CI 1.1-32.6). CONCLUSIONS: Five years after surgery, obese women continued to experience lower rates of cure compared with non-obese women.

Accuracy of Prenatal Ultrasound in Detecting Growth Abnormalities in Triplets: A Retrospective Cohort Study.

Significant management decisions in triplet pregnancies are made based mainly on ultrasound measurements of fetal growth, although there is a paucity of data examining the accuracy of fetal weight measurements in these gestations. To evaluate accuracy of prenatal ultrasound to diagnose growth abnormalities (intrauterine growth restriction, severe growth discordance) in triplet pregnancies, a retrospective cohort study of 78 triplet pregnancies (234 fetuses) delivered at a single tertiary hospital from January 2004 to May 2015 was performed. Growth percentiles from the last ultrasound were derived from estimated fetal weight using Hadlock's formula for each triplet. Growth discordance was calculated for each triplet set using the formula {(estimated fetal weight largest triplet - estimated fetal weight smallest)/estimated fetal weight largest}. These estimations were compared to birth weights. Sensitivity of ultrasound to predict ≥1 growth restricted fetus in a triplet set was 55.6% [95% CI 35.3, 74.5]; specificity was 100% [95% CI 93.0, 100]; positive predictive value (PPV) 100% [95% CI 74.7, 100]; negative predictive value (NPV) 81.0% [95% CI 73.2, 85.7%]. Sensitivity of ultrasound to detect fetal growth discordance >25% in a triplet set was 80.0% [95% CI 44.4, 97.5], specificity 94.1% [95% CI 85.6, 98.4]; PPV 66.7% [95% CI 42.4, 84.5]; NPV 97.0% [95% CI 90.2, 99.1]. Prenatal ultrasound currently remains the most reliable tool to screen for growth anomalies in triplet pregnancies; however, it appears to have less than ideal sensitivity, missing a number of cases of intra-uterine growth restriction and significant growth discordance.

The effect of hormone therapy on quality of life and breast cancer risk after risk-reducing salpingo-oophorectomy: a systematic review.

BACKGROUND: It is unclear if the use of hormone therapy (HT) in carriers of BRCA mutations improves the quality of life (QOL) without increasing the risk of breast cancer following a risk-reducing salpingo-oophorectomy (RRSO). Our objective was to assess the effect of HT on QOL and breast cancer risk, after RRSO. METHODS: We searched MEDLINE, EMBASE, CINHAL, and others, from inception to July 22, 2016, to identify relevant studies. Two reviewers independently screened identified records for controlled trials and observational studies that addressed the effect of HT on QOL and breast cancer risk in women with BRCA mutations, post RRSO. Two reviewers independently extracted data on populations, interventions, comparators, outcomes, and methodological quality. Studies addressing the same outcome were synthesized using written evidence summaries or tables. RESULTS: Of the 1,059 records identified, 13 met our inclusion criteria. All studies were observational. Six studies assessed the effect on QOL. Of these, 3 showed improvement in QOL with HT use. The risk of breast cancer was evaluated in 4 studies. The mean duration of follow-up was 2.6 years (range 0.1-19.1). The risk of breast cancer did not change with HT use in all 4 studies. CONCLUSIONS: Cumulative evidence from our review suggests that short-term HT use following RRSO improves QOL. The effect on breast cancer risk is still unclear. There are too few long-term studies to draw any strong conclusions. The need for future well-designed RCTs for more established evidence is imperative.

Retrospective Cohort Study of Cervical Pessary Use in Women with Short Cervix at Risk of Preterm Delivery.

OBJECTIVE: A paucity of effective interventions exists for the prevention of preterm birth (PTB). Renewed interest has focused on cervical pessaries, which have the benefits of being inexpensive, nonsurgical, and easily inserted and removed. In this study, we aim to describe our experience with this device in a Canadian tertiary care centre. Primary outcomes were rates of spontaneous or iatrogenic PTB before 37, 34, and 28 weeks gestation in pregnancies complicated by short cervix treated with cervical pessary. METHODS: This was a retrospective cohort study of women with singleton, twin, and triplet pregnancies with pessary placement from August 2013 to March 2015 in the Urogynecology Clinic at the Lois Hole Hospital for Women in Edmonton, AB. Included women were deemed to be at high risk of PTB due to short cervix (≤25 mm) found on ultrasound. RESULTS: Among 115 women included, pessaries were placed at a mean gestation of 25.3 weeks. Forty-nine singleton women (52.7%) delivered at term. Of these deliveries, 75% were spontaneous. Rates of PTB before 34 and 28 weeks gestation for all deliveries, respectively, were 37.4% and 10.4%. Removal data were available for 87.8% of patients, and the pessary remained in situ for a mean of 48 days. CONCLUSION: In this study's high-risk obstetrical population, the rates of preterm birth remained high. The effectiveness of pessary use, particularly when compared to other preventative strategies, remains a topic in need of further investigation. To our knowledge, this is the first study to contribute pessary data from a Canadian population.

The High Prevalence of Vitamin D Insufficiency in Cord Blood in Calgary, Alberta (APrON-D Study).

OBJECTIVE: Vitamin D is important in promoting healthy pregnancy and fetal development. We undertook this study to measure 25-hydroxyvitamin D in maternal and cord blood and to identify maternal factors related to vitamin D status in Calgary. METHODS: Blood samples collected at the time of delivery from the Alberta Pregnancy Outcomes and Nutrition study cohort (ApronStudy.ca) participants were processed for plasma and assayed using liquid chromatography mass spectrometry methodology for 25(OH)D3. RESULTS: Ninety-two pairs of maternal and cord blood samples were obtained. The prevalence of 25(OH)D3 insufficiency-25(OH)D3 <75 nmol/L-was 38% and 80% in women and neonates, respectively. Vitamin D supplementation was the only clinical factor associated with 25(OH)D3 sufficiency, and the odds of sufficiency were 3.75 (95% CI 1.00 to 14.07) higher for women and 5.27 (95% CI 1.37 to 20.27) when over 2000 IU/day were used. CONCLUSION: Using liquid chromatography mass spectrometry, we demonstrated a very high prevalence of vitamin D insufficiency in cord blood and that the use of high dose vitamin D was associated with greater odds of sufficiency in pregnant women and cord blood in Alberta.

Factors constraining patient engagement in implantable medical device discussions and decisions: interviews with physicians.

OBJECTIVE: Patient engagement (PE) is warranted when treatment risks and outcomes are uncertain, as is the case for higher risk medical devices. Previous research found that patients were not engaged in discussions or decisions about implantable medical devices. This study explored physician views about engaging patients in such discussions. DESIGN: Qualitative interviews using a basic descriptive approach. SETTING: Canada. PARTICIPANTS: Practicing cardiovascular and orthopaedic physicians. MAIN OUTCOME MEASURES: Level, processes and determinants of PE in medical device discussions and decisions. RESULTS: Views were largely similar among 10 cardiovascular and 12 orthopaedic physicians interviewed. Most said that it was feasible to inform and sometimes involve patients in discussions, but not to partner with them in medical device decision-making. PE was constrained by patient (comfort with PE, technical understanding, physiologic/demographic characteristics, prognosis), physician (device preferences, time), health system (purchasing contracts) and device factors (number of devices on market, comparative advantage). A framework was generated to help physicians engage patients in discussions about medical devices, even when decisions may not be preference sensitive due to multiple constraints on choice. CONCLUSIONS: This study identified that patients are not engaged in discussions or decisions about implantable medical devices. This may be due to multiple constraints. Further research should establish the legitimacy, prevalence and impact of constraining factors, and examine whether and how different levels and forms of PE are needed and feasible.

MEDICAL DEVICE RECALLS IN CANADA FROM 2005 TO 2015.

OBJECTIVES: Medical devices are ubiquitous in modern medical care. However, little is known about the epidemiology of medical devices in the healthcare marketplace, including the rate at which medical devices are subject to recalls or other advisories. We sought to study the epidemiology of medical devices in Canada, focusing on device recalls. In Canada, a recall may signify a variety of events, ranging from relatively minor field safety notifications, to removal of a product from the marketplace. METHODS: We used data from Health Canada to study medical device recalls in Canada from 2005 to 2015. We analyzed the risks of medical device recalls according to the risk class of the device (I lowest; IV highest) and the hazard priority of the recall (Type I highest potential harm; Type III lowest potential harm). RESULTS: During a 10-year period, there were 7,226 medical device recalls. Most recalls were for intermediate risk class (Class II, 40.1 percent; Class III, 38.7 percent) medical devices. Among recalled devices, 5.0 percent were judged to have a reasonable probability of serious adverse health consequences or death (Type I recall Hazard Priority classification). While the number of medical devices marketed in Canada is not known, over a similar 10-year period, 24,849 new Class II, II, and IV medical device licenses were issued by Health Canada. CONCLUSIONS: Several hundred medical device recalls occur in Canada each year. Further research is needed to characterize the nature of medical device recalls, and to explore how consumers use information about recalls.